Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

NCT ID: NCT00986258

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-30
• Study Completion Date: 2011-01-31

Brief Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.

Conditions

Pain; Chronic Pain; Low Back Pain; Neuropathic Pain; Nociceptive Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapentadol Prolonged Release

Other Names:

• Nucynta
• Palexia

Group Type: EXPERIMENTAL

Tapentadol Prolonged Release

Intervention Type: DRUG

Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:

• if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
• if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
• if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.

Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.

Interventions

Tapentadol Prolonged Release

Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:

• if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
• if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
• if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.

Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.

Intervention Type: DRUG

Other Intervention Names

- Nucynta; - Palexia

Eligibility Criteria

Inclusion Criteria

• Participants must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it.
• Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
• Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
• Participants must be at least 18 years of age.
• Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months
• If the Participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment.
• Participant's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
• Participants must be taking a WHO Step III analgesic on a daily basis for at least 3 months prior to the Screening Visit.
• Participants must have responded to the WHO Step III analgesic, i.e., participants must have a confirmed average pain intensity score (NRS 3) of ≤5 points during the last 3 days prior to the Screening Visit.
• Participants must report opioid-related side effects as the reason to change their analgesic.
• Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).

Exclusion Criteria

• Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
• Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
• History of alcohol or drug abuse, or suspicion of in Investigator's judgement.
• Presence of concomitant autoimmune inflammatory conditions.
• Known history of or laboratory values reflecting severe renal impairment.
• Known history of moderately or severely impaired hepatic function.
• History of or active hepatitis B or C within the past 3 months or history of HIV infection.
• History of seizure disorder or epilepsy.
• Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
• Pregnant or breast-feeding.
• History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
• Subjects with acute or severe bronchial asthma or hypercapnia.
• Subjects who have or are suspected of having paralytic ileus.
• Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
• Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
• Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product.
• Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
• Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial).
• Presence of concomitant painful condition other than low back pain that could confound the subject's trial assessments or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
• Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
• Pending litigation due to chronic pain or disability.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Schäfer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Charité University Berlin, Campus Virchow Klinikum

Locations

BE004

Bruges, , Belgium

BE003

Charleroi, , Belgium

BE002

Edegem, , Belgium

BE001

Liège, , Belgium

CZ001

Brno, , Czechia

FR004

Thionville, , France

FR001

Toulouse, , France

DE005

Albstadt, , Germany

DE001

Berlin, , Germany

DE003

Berlin, , Germany

DE006

Kiel, , Germany

DE004

Leipzig, , Germany

DE008

Leipzig, , Germany

DE007

Stuttgart, , Germany

NL002

Alkmaar, , Netherlands

NL004

Doetinchem, , Netherlands

NL003

Eindhoven, , Netherlands

NL001

Tiel, , Netherlands

PL002

Krakow, , Poland

PL001

Poznan, , Poland

ES006

Cadiz, , Spain

ES001

Granada, , Spain

ES003

Málaga, , Spain

ES004

Seville, , Spain

ES005

Valencia, , Spain

CH001

Basel, , Switzerland

CH002

Sankt Gallen, , Switzerland

Countries

Belgium; Czechia; France; Germany; Netherlands; Poland; Spain; Switzerland

References

Galvez R, Schafer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Adv Ther. 2013 Mar;30(3):229-59. doi: 10.1007/s12325-013-0015-6. Epub 2013 Mar 7.

Reference Type: RESULT

PMID: 23475406 (View on PubMed)

Other Identifiers

2009-010428-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KF5503/45

Identifier Type: OTHER

Identifier Source: secondary_id

835093

Identifier Type: -

Identifier Source: org_study_id